Dictionary: Once a drug has been approved for 18-months or has been used by 10,000 patients, whichever is later, a summary analysis of the adverse drug reaction reports received for the drug is included, including identification of any new risks not previously identified, potential new risks, or known risks reported in an unusual number

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Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.